Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations)
Corcept Therapeutics
Corcept Therapeutics seeks a Senior Specialist to support patient safety and pharmacovigilance operations for clinical trials. The role involves quality review of safety reports, data reconciliation, regulatory compliance, and cross-functional collaboration to ensure accurate and timely safety reporting across company-sponsored studies and expanded access programs.
Responsibilities
- Conduct quality reviews of clinical trial safety reports for completeness and regulatory compliance
- Reconcile safety data between investigator reports, EDC systems, and safety databases
- Generate and resolve safety follow-up queries with study teams and contract research organizations
- Review and ensure accurate, timely submission of expedited and aggregate safety reports
- Support process improvement, training development, and audit preparation activities
Requirements
- Bachelor's degree in healthcare or life sciences; RN, BSN, or PharmD preferred
- 3 years of pharmacovigilance operations experience in pharmaceutical or biotechnology
- Proficiency with Argus safety applications and EDC systems such as Medidata RAVE
- Strong communication and cross-functional collaboration abilities
- Ability to manage multiple concurrent projects in fast-paced environment
- Up to 10% travel capability
Vacancy posted 10 days ago
Similar jobs that could be interesting for youBased on the Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations) in Redwood City, CA vacancy
$65.8k - $87k
...Specialist I, Patient Safety and Pharmacovigilance Operations Redwood City, California, United States For more than 25 years, Corcept has been singularly... ...receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors,...OperationsFull timeWork at office3 days per week- ...Corcept Therapeutics seeks a Patient Safety and Pharmacovigilance Operations Specialist to manage safety intake channels, triage adverse event reports, and... ...routing of safety information in postmarketing and clinical trial settings. Responsibilities Monitor and triage...OperationsWork at office
- Corcept Therapeutics is seeking a Safety Operations professional to manage PSPV mailboxes and safety intake channels in postmarketing and clinical settings. You will review communications, identify potential adverse events, IAOs, and QA issues, and ensure timely routing...Operations
$275k - $300k
...Senior Medical Director, Clinical DevelopmentDren Bio is a privately... ...offering a superior safety profile compared... ..., Clinical Operations, Regulatory, Patient Safety, Medical Affairs... ...review clinical trial documentsProvide... ...collaboration with pharmacovigilance function)Conduct...OperationsSeniorTemporary workLocal areaDren Bio
San Carlos, CA3 days ago$186k - $233k
...innovative medicines for patients with RAS-addicted... ...Opportunity:The Senior Safety Scientist within... ...science and pharmacovigilance support to all... ...safety oversight of clinical studies, review... ...authoring of clinical trial protocols, IBs,... ...RevMed standard operating procedures (SOPs)...OperationsSeniorFull timeLocal areaWorldwideRevolution Medicines
Redwood City, CA3 days ago- ...company in the search for a Senior Clinical Trial Manager. This is a newly... ...Responsibilities Lead the operational planning and execution of... ...Management, Biostatistics, Pharmacovigilance, Clinical Supply, and... ...escalation plans. Oversee patient recruitment and retention...OperationsSenior3 days per week
- ...Senior Director role overseeing patient safety and pharmacovigilance for Corcept's investigational and marketed products. Responsible for safety monitoring, signal... ...risk management, and regulatory reporting across clinical and post-marketing settings. Responsibilities...Senior
$149k - $170k
...Senior Clinical Research AssociateRedwood City, California, United StatesFor... .... With advanced clinical trials in patients with hypercortisolism,... ...practices (GCPs), standard operating procedures (SOPs), and study... ...study reports for accuracy, safety, and/or efficacy trends; as...OperationsSeniorFull timeInterim roleWork at office3 days per weekCorcept Therapeutics
Redwood City, CA1 day ago- ...Foundation is seeking a Medical Office Representative to greet patients and provide exceptional service. You will be the primary... ...electronic practice management system. You will support daily clinic operations with empathy and efficiency. Must be able to handle multiple...OperationsWork at office
$10k
...Sprinter Health Patient Engagement Specialist I At Sprinter Health, we're focused on dramatically... ...scale. Sprinter Health is building the clinical and technological infrastructure to... ...Role We are rapidly expanding our operations as we build new partnerships across...OperationsTemporary workRelocation packageFlexible hours- ...Office Representative in California. You will greet patients and visitors, handle incoming calls, and... ...eligibility, and schedule appointments using the clinic’s electronic system. This role supports daily operations and patient care initiatives with reliability and...OperationsWork at office
$173.43k - $204.03k
...receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors,... .... To learn more, visit The Senior Manager of Clinical Quality Assurance... ...perform day-to-day clinical quality operations and compliance activities to support...OperationsSeniorFull time3 days per weekCorcept Therapeutics
Redwood City, CA4 days ago$298k - $350.6k
...Lead Medical Safety Physician Redwood City,... ...antagonists. With advanced clinical trials in patients with... ...of Patient Safety & Pharmacovigilance, this role will be responsible... ...marketing programs. Operate as a peer functional... ...Provide senior medical safety leadership...OperationsFull time- ...Redwood City, California is seeking a Surgical Tech to join the operating room team across all phases of procedures. You will prepare... ...instruments while maintaining a sterile field to ensure patient safety. The role requires strong attention to detail, excellent organization...Senior
- Stanford Health Care in Redwood City is seeking a Patient Administrative Specialist to coordinate new patients, schedule surgeries, and support front-office operations in the outpatient clinic. You will greet patients, complete registrations, verify insurance, handle calls...Operations
$244k - $305k
...innovative medicines for patients with RAS-addicted... ...creative and collaborative Senior Director to work in a... ...report to the Head of Clinical Biomarker Development... ...Development, Clinical Operations, Biostatistics,... ...and Phase 3 clinical trials is desirable. #LI-Hybrid...OperationsSeniorFull timeLocal areaWorldwideRevolution Medicines
Redwood City, CA1 day ago$33.05 - $37.21 per hour
...Overview The primary responsibility of the Patient Administrative Specialist (PAS) is to handle new patient... ...office functions in the outpatient clinical setting. A Patient Administrative Specialist... ...tasks related to the daily operations of the clinic. The career progression...OperationsHourly payFull timeWork at office$146k - $161k
...Clinical Trial Manager/Senior Clinical Trial ManagerWaltham, Massachusetts, United StatesOruka Therapeutics... .... Oruka's mission is to offer patients suffering from chronic skin diseases... ...compliance, regulatory alignment, and operational efficiency while collaborating with...OperationsSeniorWork at officeRemote work3 days per weekOruka Therapeutics
Menlo Park, CA7 hours ago- Guardant Health, Inc. in Redwood City, CA is seeking a Senior Environmental Health and Safety Specialist to implement policies and ensure a safe, compliant... ..., and collaborate with Facilities, Laboratory Operations, Engineering, and People Operations while keeping up...OperationsSenior
- ...Manager Responsible for overseeing employees and directing operations of the Hearing Center and other areas of the warehouse. Addresses... ...product storage, and cash handling. Implements and upholds safety and security procedures. Ensures all minimum licensing requirements...OperationsSeniorFull timeTemporary workApprenticeshipWork at office
$244k - $305k
...innovative medicines for patients with RAS-addicted... ...unique opportunity for a Clinical Operations Professional who has... ...management of clinical trial vendor agreements budgets... ..., Data Management, Safety, Regulatory, Quality,... ...challenges, serving as the senior escalation point for...OperationsSeniorFull timeContract workLocal areaWorldwideRevolution Medicines
Redwood City, CA2 days ago$164k - $205k
...and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging... ...Opportunity:This is a unique opportunity for a Clinical Operations Professional. As a Sr. Clinical Program... ...Revolution Medicines (RevMed) clinical trials.Responsibilities:Adhere to Clinical...OperationsSeniorFull timeContract workTemporary workWork at officeLocal areaWorldwideRevolution Medicines
Redwood City, CA4 days ago- ...City is seeking a part-time dishwasher to support kitchen operations in a friendly senior-care setting. You will clean and sanitize dishes,... ...training. The role emphasizes teamwork and adherence to safety standards. We offer competitive pay, benefits starting at...OperationsSeniorPart time
$110k - $115k
...Level Reliability Centered Maintenance Specialist (RCM)EMCOR Government Services is seeking... ...failure investigations, corrective actions, safety, regulatory compliance, and overall... ...maintenance strategy documents and standard operating procedures (SOPs).· Assist in ranking...OperationsWork at officeEMCOR Group
Redwood City, CA20 hours ago$110.2k - $151.5k
...2012, Guardant® is transforming patient care and accelerating new cancer... ...and Facebook. Position Summary The Senior Environmental Health and Safety Specialist is responsible for implementing Guardant... ...Health & Safety (EHS) operations at Guardant Health's Corporate Headquarters...OperationsSeniorWork experience placementWork at officeLocal areaWork from homeGuardant Health
Redwood City, CA2 days ago$215k - $230k
...medicines for rare disease patients. We are collaborative... ...Director of Medical Safety Science (Safety... ...in post-marketing and clinical trial settingGenerate outputs... ...safety surveillance/pharmacovigilance activities such as... ...documents such as Joint Operating Guidelines, Monthly...OperationsLocal areaMirum Pharmaceuticals
Foster, CA3 days ago- ...therapeutics for patients with serious or... ...strategic and operational leadership for the clinical development of... ...Affairs, Biometrics, Pharmacovigilance, CMC, and... ...structured as Senior Vice President,... ...ongoing clinical trials, including... ...interpretation of safety, efficacy, pharmacokinetic...OperationsSeniorWork at officeLocal area
- A healthcare technology company is seeking a Patient Scheduling Support Representative to manage real-time patient communication and... ...email, and phone. The ideal candidate has 3-5 years in healthcare operations and proficiency in tools like AthenaHealth and Zendesk. This...OperationsRemote job
- ...ApplicationsEmail: ****@*****.*** Opportunity: Senior Clinical Program Manager, Clinical Operations Compliance & TrainingThis is a unique opportunity... ...and inspection readiness throughout the clinical trial lifecycle.Support Clinical Operations Inspection...OperationsSeniorWork at office
Planet Pharma
Redwood City, CA2 days ago - ...today has hundreds of megawatts in advanced development and field operations for leading Fortune 500 companies, data centers, and utilities.... ...mills, lathes, and traditional machines. Maintains quality and safety standards and maintains supplies and equipment. Duties and...OperationsSeniorLocal areaFlexible hours
Mainspring Energy
Menlo Park, CA17 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations). Be the first to apply!
Related searches
- grocery specialist Redwood City, CA
- localization specialist Redwood City, CA
- restaurant specialist Redwood City, CA
- renovation specialist Redwood City, CA
- maintenance specialist Redwood City, CA
- welding specialist Redwood City, CA
- criminal justice specialist Redwood City, CA
- mathematics specialist Redwood City, CA
- event production specialist Redwood City, CA
- international relations specialist Redwood City, CA